您搜索了: referencemedlemsstatens (丹麦语 - 英语)

referencemedlemsstatens anerkendelsesprocedure
- the mrp assessment report of the rms

referencemedlemsstatens produktresumé blev ændret.
the summary of product characteristics of the reference member state was amended.

referencemedlemsstatens senest godkendte produktresumé forbliver uændret.
the latest approved summary of the product characteristics of the reference member state remains unchanged.

referencemedlemsstatens kompetente myndighed vurderer den indgivne ansøgning.
the competent authority of the reference member state shall assess the application submitted.

c) kan referencemedlemsstatens kompetente myndighed forlænge den i stk.
(c) the competent authority of the reference member state may extend the period referred to in paragraph 2.

referencemedlemsstatens kompetente myndighed underretter de øvrige berørte kompetente myndigheder.
the competent authority of the reference member state shall inform the other competent authorities concerned.

kan referencemedlemsstatens kompetente myndighed forlænge den i stk. 2 omhandlede frist.
the competent authority of the reference member state may extend the period referred to in paragraph 2.

referencemedlemsstatens kompetente myndighed underretter straks indehaveren og de øvrige kompetente myndigheder herom.
the competent authority of the reference member state shall forthwith inform the holder and the other competent authorities concerned accordingly.

referencemedlemsstatens kompetente myndighed underretter de øvrige kompetente myndigheder i de berørte medlemsstater herom.
the competent authority of the reference member state shall inform the other competent authorities of the member states concerned to this effect.

underretter referencemedlemsstatens kompetente myndighed de øvrige berørte kompetente myndigheder om dens anmodning om supplerende oplysninger
the competent authority of the reference member state shall inform the other competent authorities concerned of its request for supplementary information;

referencemedlemsstatens kompetente myndighed afslutter proceduren og meddeler de øvrige berørte kompetente myndigheder og indehaveren dette.
the competent authority of the reference member state shall close the procedure and shall inform the other competent authorities concerned and the holder accordingly.

a) underretter referencemedlemsstatens kompetente myndighed de øvrige berørte kompetente myndigheder om dens anmodning om supplerende oplysninger
(a) the competent authority of the reference member state shall inform the other competent authorities concerned of its request for supplementary information;

anbefalede chmp udstedelse af markedsføringstilladelse( r) og ændring af referencemedlemsstatens produktresumé, etikettering og indlægsseddel.
the chmp has recommended the granting of the marketing authorisation(s) , as well as the text to be included in the summary of product characteristics, package leaflet and labelling.

referencemedlemsstaterne afholdt i alt 36 udbrydermøder (vedrørende 29 nye ansøgninger og 7 ændringer).
a total of 36 breakout sessions were organised by reference member states (referring to 29 new applications and 7 variations).